Finding studies
Finding studies
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Lead
The University of Texas Health Science Center at San Antonio
With
OBJECTIVES: * Determine the antitumor activity of erlotinib in patients with advanced renal cell carcinoma. * Evaluate the safety and tolerability, in terms of the toxicity profile, of this drug in these patients. * Determine the biologic activity of this drug, in terms of early disease progression, progression-free survival, 12-month survival rate, and overall survival, in these patients. * Determine the pharmacodynamics of this drug in these patients. * Analyze the postreceptor effects of epidermal growth factor receptor-tyrosinase kinase inhibition by this drug on cell cycle, apoptosis, and angiogenesis in tumor biopsies from these patients. * Correlate changes in biological measurements with indices of outcome in patients treated with this drug. OUTLINE: This is an open-label, multicenter study. Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 4 weeks for 52 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 19-40 patients will be accrued for this study within 8-10 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted